Clinical Research Coordinator: Impactful Trials & Compliance

Duke University Health System; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Duke University Health System in Durham, NC seeks a Clinical Research Coordinator to manage complex clinical studies, regulatory tasks, and data collection across multiple therapeutic areas. You will work with principal investigators to ensure protocol compliance and quality of data across study sites.

Responsibilities include coordinating data collection, preparing analyses, and supporting manuscript development while maintaining IRB approvals and safety reporting.

Qualifications

• Graduation from an accredited clinical degree program and healthcare experience.
• Equivalent combinations of relevant education and/or experience may apply.
• Additional regulatory and clinical research knowledge is beneficial.

Responsibilities

• Coordinate and participate in clinical research studies conducted by principal investigators at Duke University Medical Center.
• Coordinate data collection from patient charts, medical records, interviews, questionnaires and tests; prepare documentation.
• Ensure compliance with protocol guidelines and regulatory requirements; monitor progress and report adverse events.
• Evaluate and interpret collected clinical data with investigators; prepare reports and discuss results.
• Collaborate on manuscript preparation and development of study manuals and data collection forms.
• Review literature to inform planning of new studies.
• Assure regulatory compliance; develop and maintain regulatory documents and IRB approvals.
• Perform regulatory audits and address findings; lead regulatory educational events.
• Assist in amendments to protocols and guide lower-level personnel; train new staff.

Education

BSN, PA, or Pharmacist degree plus two years healthcare experience

Allied health degree or Associate’s in Clinical Trials Research + five years healthcare/research experience

Bachelor’s degree in health science + three years related clinical/research experience

Job description

Duke University Health System in Durham, NC seeks a Clinical Research Coordinator to manage complex clinical studies, regulatory tasks, and data collection across multiple therapeutic areas. You will work with principal investigators to ensure protocol compliance and quality of data across study sites.

Responsibilities include coordinating data collection, preparing analyses, and supporting manuscript development while maintaining IRB approvals and safety reporting.